Advanced Wound Therapy with mVASC
Learn more about how mVASC can transform microvascular tissue regeneration


MVT has developed a way to stabilize the components of microvascular tissue into an off-the-shelf product that capitalizes on the powerful angiogenic properties of microvascular fragments. mVASC® is a human microvascular tissue allograft that has been processed and lyophilized, while preserving structural tissue fragments, associated nonviable cells, and inherent biological factors that enhance healing potential by increasing blood supply, regulating the immune cell reaction, modulating inflammation, and providing the foundation for tissue repair. mVASC is terminally sterilized and room temperature stable for 5 years.
mVASC is marketed in accordance with FDA HCT/P regulations, and is restricted to homologous use for the repair, reconstruction, replacement or supplementation of microvascular tissues. It can be used wherever microvascular deficiencies exist. For example, mVASC can be added to a nonhealing wound to restore blood flow.
The composition and function of mVASC has been extensively studied. Characterization of structural and biologic factors intrinsic to mVASC shows that key angiogenic and neurotrophic factors in microvascular tissue are preserved. Recognized preclinical models, including mouse pressure ulcer and hindlimb ischemia studies demonstrated that mVASC improved healing, and increased neovascularization and blood flow, respectively.
mVASC demonstrates significantly greater re-perfusion and vascular reconstruction in a recognized mouse angiogenesis model.
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mVASC significantly increased the rate of wound healing in a recognized mouse pressure ulcer model, demonstrating its potential as an advanced treatment for restoring normal tissue function in ischemic wounds.
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mVASC demonstrates significantly more newly formed blood vessels and more mature (larger diameter) vessels in a recognized angiogenesis model.
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Nonhealing diabetic foot ulcers (DFUs) are stalled wounds with compromised repair capabilities. Less than one quarter of these ulcers will heal with standard wound care after 12 weeks. 1
The large clinical and economic burden of nonhealing DFUs continues to escalate, and includes multiple admissions, treatment for infection, neuropathy, and amputations. Up to 34% of the 34 million diabetics in the US will develop a DFU during their lifetime.2,3 Despite use of advanced therapeutics, the 5-year mortality after amputation from a diabetic foot ulcer is over 45%.4
In addition to addressing the compromised vasculature contributing to a nonhealing DFU, microvascular tissue also has the potential to impact the loss of sensation common in diabeties. Leaky capillary walls in diabetic tissue decrease blood flow to the surrounding microvascular tissues, resulting in structural changes that also damage the nerves, and ultimately leading to neuropathy associated with the occurrence and recurrence of DFUs. 5,6
A functioning microvasculature is crucial for closing nonhealing wounds and re-establishing a normal environment that translates into well-perfused, sensate, high quality tissue.
1Margolis D, et al. Diabetes Care. 22:692 (1999). (25% healed at 12w)
2Armstrong DG, et al. N Engl J Med. 376:24 (June 2017). (up to 34% of 34M)
3National Diabetes Statistics Report, 2020. (up to 34% of 34M)
4Armstrong DG, et al. J Foot Ankle Res. 13:16 (2020). (5y mortality <45%)
5Thrainsdottir S, et al. Diabetes. 52:2615 (2003). (vascular changes lead to neuropathy)
6Lavery L, et al. Arch. Intern. Med. 158:157 (1998). (neuropathy predictor of DFU)
MVT recently completed the HIFLO trial (HEALING IN DIABETIC FOOT ULCERS WITH MICROVASCULAR TISSUE). The HIFLO trial is a multi-center Level 1 prospective 100-patient randomized controlled trial of allogeneic microvascular tissue (mVASC) in nonhealing neuropathic diabetic foot ulcers.
The HIFLO trial represents a new bar for evaluating advanced wound products. The study utilized four predefined criteria and an independent blinded panel of three adjudicators to determine closure, included a real-world patient population of Wagner 1 and 2 DFUs (uncommon in a large RCT), and is the first large RCT to include sub studies involving perfusion and peripheral neuropathy.
mVASC is unique among advanced wound therapies, as it represents a ‘biological matching’ of the solution to a disease state. The HIFLO trial represents the first demonstration of using microvascular elements to treat microvascular dysfunction in a randomized study. By leveraging intrinsic healing mechanisms, mVASC achieved superior wound closure and quality of healing, including a marked improvement in wound regional blood flow and significant increases in local and regional sensation.
Overall, mVASC increased the odds of healing by 9 times over standard of care treatment. The higher percentage of closed ulcers and faster time to healing with mVASC may mitigate some of the risk factors associated with DFU complications, such as infection, reoccurrence and amputation. The improvements in blood flow and neuropathy may also mitigate these risk factors, though additional studies should be performed.
Learn more about how mVASC can transform microvascular tissue regeneration
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